In the past four years, two European hospitals have reported 25 cases of a rare disease called nephrogenic fibrosing dermopathy or nephrogenic systemic fibrosis, detected each time following the injection of a gadolinium-based MRI contrast agent called Omniscan, according to an report posted on the ACR web site. GE Healthcare, which manufactures the agent, released a safety update on June 6 stating that it is working with the FDA, the Danish Medicines Agency, and EU regulatory authorities to determine whether a causal relationship exists between the injection and the disease. To date, no relationship has been established. NFD/NSF is a rare condition occurring in patients with chronic renal function impairment; there is no evidence that other patient groups are at risk for the disease. It causes increased formation of connective dermal tissue, thickening skin and potentially leading to contractures. GE estimates that about 30 million patients have been administered Omniscan since its approval for marketing in 1993.
